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510(k) Data Aggregation

    K Number
    K140683
    Device Name
    0180 INTUITION, 0072 PRECISION
    Manufacturer
    ARCOMA AB
    Date Cleared
    2014-06-03

    (77 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARCOMA AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These are stationary x-ray systems intended for obtaining radiographic images of various portions of the human body in a clinical environment. The devices are not intended for mammography
    Device Description
    This is a complete stationary diagnostic x-ray system employing digital x-ray panels coupled with image acquisition software. The key features are: Ceiling Tube Suspension, Motorized Movements, Auto-Positioning, Tube Mounted 10" Touch Screen, Elevating 6 Way Table Patient Load: 5501bs, Single User Interface, High Frequency Generator. This ergonomic design incorporates automatic motorized positioning, creating an efficient workflow increasing the patient throughput. Precision offers automatic stitching enhancing the workflow further. Tube, vertical wall stand and table have extended range of motion for easy patient positioning. The acquisition software is installed on a Windows compatible workstation. The high frequency generator is available in different power ratings. All components are either 510(k) exempt or previously cleared. Generators are available in 50, 65, 80 kW (High Frequency) models.
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    K Number
    K073632
    Device Name
    INTUITION, MODEL 0170
    Manufacturer
    ARCOMA AB
    Date Cleared
    2008-01-10

    (15 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARCOMA AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 0170 Intuition is a stationery x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment. The 0170 Intuition is not intended for mammography.
    Device Description
    The 0170 Intuition is a stationary x-ray system with a ceiling mounted tube stand, a floor mounted table and a wall stand that has a floor mounted column with a detector holder. The ceiling stand and the table has automatic movements for up and downs, other movements are manual. The standard equipment includes a graphic display showing X-ray tube rotation and film focus or source image distance.
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